Azienda USL Toscana Sud-Est Pneumology Department, "Misericordia" Hospital, Grosseto, Italy,
Experimental Medicine and Systems, "PhD Program" Department of Systems Medicine University of Rome "Tor Vergata", Rome, Italy,
Int Arch Allergy Immunol. 2021;182(4):311-318. doi: 10.1159/000511147. Epub 2020 Oct 28.
It is not clear whether mepolizumab is differently effective in allergic and nonallergic severe eosinophilic asthmatics (SEA) in real life.
We tested mepolizumab effectiveness in allergic/nonallergic SEA in real life. A strict criterion to identify the 2 phenotypes was used.
We retrospectively considered 134 consecutive patients divided into allergic, with a positivity to at least 1 allergen to prick tests and/or IgE values ≥100 UI/mL (severe allergic eosinophilic asthma [SAEA]; n: 97-72.4%), and nonallergic, with no prick test results and normal IgE levels <100 UI/mL (severe nonallergic eosinophilic asthma [SNAEA]; n: 37-27.6%). They had taken mepolizumab for at least 6 months.
After 10.9 ± 3.7 months, improvements in FEV1%, FEF25-75%, exacerbation numbers, blood eosinophil (BE) counts, fractional exhaled nitric oxide (FENO) (ppb), percentages of patients that stopped/reduced short-acting β2-agonists (SABAs) or oral corticosteroid (OC), observed after treatment, were similar in both groups. Only Asthma Control Test (ACT) increases were higher in SNAEA (8 [5-9]) than in SAEA (5 [2.5-8.5]; p = 0.016). However, no differences were found after treatment in percentages of subjects with ACT ≥20, as well as with FEV1 >80%, FEF25-75 >65%, exacerbations ≤2, BE <300 cells/µL, and FENO <25 ppb between SAEA and SNAEA. Besides, no significant relationships were found, comparing SNAEA with SAEA, for FEV1% (β = -0.110; p = 0.266), FEF25-75% (β = -0.228; p = 0.06), BE counts (β = -0.012; p = 0.918), FENO (β = 0.234; p = 0.085), ACT (β = 0.046; p = 0.660), and exacerbations (β = -0.070; p = 0.437). No different associations between lung function and SNAEA occurrence when compared to SAEA condition (FEV1 >80%: OR = 1.04 [95% CI: 0.43-2.55], p = 0.923; FEF25-75 >65%: OR = 0.41 [95% CI: 0.08-2.03], p = 0.272) were detected. Neither all other parameters, such as ACT >20 (OR = 0.73 [95% CI: 0.32-1.63], p = 0.440), presence of exacerbations (OR = 1.35 [95% CI: 0.55-3.27], p = 0.512), SABA discontinuation (OR = 1.16 [95% CI: 0.40-3.39], p = 0.790), and OC cessation/reduction (OR = 3.44 [95% CI: 0.40-29.27], p = 0.258), were differently associated with 1 or the other phenotype.
Mepolizumab can be considered as a valid therapeutic choice for either allergic or nonallergic SEA in real life.
目前尚不清楚美泊利珠单抗在现实生活中的过敏性和非过敏性重度嗜酸性粒细胞性哮喘（SEA）患者中的疗效是否存在差异。
我们旨在检验美泊利珠单抗在现实生活中对过敏性/非过敏性 SEA 的疗效。本研究采用严格的标准来鉴定这两种表型。
我们回顾性地考虑了 134 例连续患者，这些患者被分为过敏性组和非过敏性组。过敏性组至少有 1 种过敏原皮试阳性和/或 IgE 值≥100 UI/mL（重度过敏性嗜酸性粒细胞性哮喘 [SAEA]；n：97-72.4%），非过敏性组无皮试结果且 IgE 水平正常<100 UI/mL（重度非过敏性嗜酸性粒细胞性哮喘 [SNAEA]；n：37-27.6%）。所有患者均接受了至少 6 个月的美泊利珠单抗治疗。
治疗 10.9±3.7 个月后，两组患者的 FEV1%、FEF25-75%、恶化次数、血嗜酸性粒细胞计数、呼出气一氧化氮（FENO）（ppb）、停止/减少短效β2-受体激动剂（SABA）或口服皮质类固醇（OC）的患者比例均有改善。然而，与 SAEA 相比，SNAEA 组的哮喘控制测试（ACT）评分增加（8 [5-9]）更高（p=0.016）。然而，治疗后两组 ACT≥20%的患者比例、FEV1>80%、FEF25-75>65%、恶化次数≤2、血嗜酸性粒细胞计数<300 细胞/µL 和 FENO<25 ppb 的患者比例均无差异。此外，比较 SNAEA 与 SAEA 组时，FEV1%（β=-0.110；p=0.266）、FEF25-75%（β=-0.228；p=0.06）、血嗜酸性粒细胞计数（β=-0.012；p=0.918）、FENO（β=0.234；p=0.085）、ACT（β=0.046；p=0.660）和恶化次数（β=-0.070；p=0.437）均无显著相关性。与 SAEA 相比，SNAEA 与肺功能之间也没有不同的关联（FEV1>80%：OR=1.04 [95%CI：0.43-2.55]，p=0.923；FEF25-75>65%：OR=0.41 [95%CI：0.08-2.03]，p=0.272）。其他参数，如 ACT>20（OR=0.73 [95%CI：0.32-1.63]，p=0.440）、恶化（OR=1.35 [95%CI：0.55-3.27]，p=0.512）、SABA 停药（OR=1.16 [95%CI：0.40-3.39]，p=0.790）和 OC 停药/减量（OR=3.44 [95%CI：0.40-29.27]，p=0.258）与 1 种或另 1 种表型也没有不同的相关性。
在现实生活中，美泊利珠单抗可以被视为治疗过敏性和非过敏性 SEA 的有效治疗选择。
